This invention relates to lavage. In one aspect, the invention relates to a kit for performing a joint, e.g., knee, lavage in an out-patient setting while in another aspect, the invention relates to a protocol for performing a joint lavage in an out-patient setting. In yet another aspect, the invention relates to a protocol for the treatment of osteoarthritis of the knee by using knee lavage in combination with sodium hyaluronate or hylan.
Osteoarthritis of the knee is an ailment common to a large segment of the elderly population of the United States. Pain and diminished function are common traits of the ailment, and various protocols exist for the treatment of this ailment. Total knee arthroplasty has proven successful for patients with end-stage osteoarthritis of the knee but due to its expense and relatively high failure rate for those patients with active lifestyles, it has not been as available and/or successful for patients with non-end-stage osteoarthritis of the knee. For this latter group of patients, protocols employing hylan or sodium hyaluronate have demonstrated considerable success.
Hyaluronic acid is a natural constituent of synovial fluid and cartilage. The function of the hyaluronic acid is to maintain structural and functional characteristics of extracellular matrix and fluids. Presently two products are composed of various fractions of hyaluronate are approved by the United States Food and Drug Administration for relief of pain associated with osteoarthritis of the knee for patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics. These products are sodium hyaluronate sold under the trademark HYALGAN(trademark) and hylan-G-F-20 sold under the trademark SYNVISC(trademark). Both of these products are classified as prosthetic devices. Various protocols exist for use of these products, and a typical protocol for sodium hyaluronate is a series of injections over five weeks. For hylan-G-F-20, a typical protocol is a series of injections over three weeks.
One limitation on these treatments of non-end-stage osteoarthritis of the knee is the cost associated with the performance of this procedure in a hospital setting. As is well known, the cost associated with just about any medical procedure performed within a hospital setting as compared to the procedure performed in an out-patient setting (i.e., an out-patient clinic, a physician""s office, a patient""s home, etc.) is often much larger. As such, a recognized need exists for a joint lavage kit and protocol for use in an out-patient setting in order to minimize expenses and complications such as infections. Moreover, the medical profession has a continuing interest in improving any of the existing protocols for treatment of osteoarthritic joints.